Efficacy of a Fixed-Dose Combination of Trandolapril-Verapamil in Patients with Stage 2 Hypertension Inadequately Controlled by Monotherapy

Rubio-Guerra, Alberto Francisco; Arceo-Navarro, Adalberto; Lozano-Nuevo, José Juan; Vargas-Ayala, Germán; Rodríguez-López, Leticia; Ramos-Brizuela, Luz María

doi:10.2165/00044011-200525070-00003

Cited by 5 publications

(4 citation statements)

References 11 publications

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“…In a similar study conducted by Rubio-Guerra et al, the fixed-dose combination of trandolapril 2 mg and verapamil 180 mg was also found to be effective in the control of hypertension, with most patients having significant BP reductions and reaching the recommended therapeutic goals [ 16 ]. In the Tr/Ve study [ 17 ] conducted for the evaluation of the efficacy and safety of the verapamil SR and trandolapril combination, it was shown that the combination therapy in a single pill in the SR formulation was more effective than the use of the active ingredients of the combination and placebo in 631 patients with hypertension through 10 weeks of therapy.…”

Section: Discussionmentioning

confidence: 99%

A Prospective Noninterventional, Observational Study to Describe the Effectiveness and Safety of Trandolapril and Verapamil Single-Pill Combination in the Management of Patients with Hypertension and Type 2 Diabetes Mellitus: A Harvest TR Study

Atalar

Eskin

Tugtekin

et al. 2020

BioMed Research International

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Maintaining regular blood pressure control usually requires multidrug regimens rather than monotherapy. The objective of this study was to describe the effectiveness and safety of an angiotensin-converting enzyme inhibitor and a nondihydropyridine calcium channel blocker in a single-tablet combination in patients with hypertension, a heart rate higher than 70 beats/min, and type 2 diabetes mellitus (T2DM). This study was conducted in Turkey as a prospective, noninterventional, observational study. At 22 clinical sites, the data of 200 patients with hypertension were used for efficacy analysis; however, 262 patients received at least one dose of trandolapril/verapamil fixed-dose combination at two dose strengths. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, PR interval, glycated haemoglobin (HbA1c), and albumin/creatinine ratios were recorded during 8 weeks of treatment. With treatment, the mean (±SD) SBP that was recorded as 162.8 (±14.642) mm Hg at baseline was reduced to 131.7±11.1 mm Hg at week 8 (p<0.05). Similarly, the mean DBP was reduced from 93.76±9.16 mm Hg to 77.6±7.6 mm Hg (p<0.001). Following 8 weeks of treatment, SBP and DBP values were reduced below 140 mm Hg and 90 mm Hg in most patients (81.5%), respectively. The mean heart rate as evaluated using electrocardiography measurements was reduced to 78.25 beats/min at week 8 as compared with baseline during trandolapril/verapamil single-pill combination treatment (p<0.001). Treatment with trandolapril and verapamil was well tolerated over 8 weeks with no unexpected safety signals. In conclusion, the single-pill combination of trandolapril and verapamil was considered effective in reducing and controlling blood pressure in patients with hypertension and T2DM. There was a significant improvement in HbA1c and ACR levels in a smaller subgroup of the patient cohort. The trandolapril/verapamil combination was evaluated as being safe and well-tolerated following a treatment period of 8 weeks. This trial was registered with NCT02298556.

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Section: Discussionmentioning

confidence: 99%

A Prospective Noninterventional, Observational Study to Describe the Effectiveness and Safety of Trandolapril and Verapamil Single-Pill Combination in the Management of Patients with Hypertension and Type 2 Diabetes Mellitus: A Harvest TR Study

Atalar

Eskin

Tugtekin

et al. 2020

BioMed Research International

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“…Clinical studies and observational analyses have also demonstrated the beneficial effects of fixed-dose therapy on BP control rates [17][18][19]. In addition, there are data showing that fixed-dose combination therapy may achieve BP control more promptly than the standard practice of starting with a single agent, titrating, and then adding a second drug [20][21][22].…”

Section: Rationale For the Use Of Combination Therapy In Stage 2 Hypementioning

confidence: 99%

Improving blood pressure control and clinical outcomes through initial use of combination therapy in stage 2 hypertension

White

2008

Blood Pressure Monitoring

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Poor control of clinic and 24-h blood pressure (BP) is associated with enhanced risk of all cardiovascular disease events. Certain patient groups including the elderly, African-Americans, and those with hypertension and comorbid disease are difficult to control, as are patients with stage 2 hypertension (systolic BP>or=160 mmHg or diastolic BP>or=100 mmHg). It has been estimated that more than two-thirds of high-risk hypertensive patients with stage 2 hypertension and all hypertensive patients with diabetes mellitus or kidney disease will require two or more antihypertensive agents from different therapeutic classes to reach BP goals. Combining agents with distinct and complementary modes of action can address different pathophysiologic mechanisms involved in hypertension and may lead to more complete and prompt reductions in BP. Tolerability may also improve, as certain classes of antihypertensive agents ameliorate adverse effects associated with other agents. Patients may benefit from fixed-dose combinations of drugs as this simplifies the regimen and may improve adherence with therapy, control of BP, and ultimately lead to reductions in cardiovascular events. Recent data and treatment guidelines support the use of a combination strategy as 'initial' antihypertensive therapy in high-risk patients with stage 2 hypertension.

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“…Clinical trials in patients with stage 2 hypertension have consistently shown the benefit of combining a CCB with an ACE inhibitor 35,46,47 . Recent trials have also established the efficacy and tolerability of combining an ARB with a CCB in high‐risk populations, including patients with stage 2 hypertension 41,42,48 …”

Section: Clinical Trials Of Ccbs Plus Ras Inhibitors In High‐risk Popmentioning

confidence: 99%

Prompt, Aggressive BP Lowering in High‐Risk Patients

Jamerson

Basile

2008

J of Clinical Hypertension

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Various populations with hypertension have been singled out by current treatment guidelines as requiring more specific treatment. These include patients with stage 2 hypertension, black patients, and patients with coexistent diabetes mellitus and coronary heart disease. Hypertension in these groups is often associated with higher risk of cardiovascular morbidity and mortality. This article reviews current knowledge regarding hypertension in high-risk patient populations, with a particular focus on the importance of prompt, aggressive treatment to lower blood pressure and prevent cardiovascular disease progression. Such treatment includes the early use of multiple-drug therapy with agents that have complementary blood pressure-lowering mechanisms and provide protection from target organ damage. While 2- or 3-drug antihypertensive therapy in these high-risk groups has typically included a diuretic, other combinations of agents may be indicated. Evidence suggests that therapy with a calcium channel blocker and an inhibitor of the renin-angiotensin system is one effective strategy for lowering blood pressure and improving outcomes in these populations.

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Efficacy of a Fixed-Dose Combination of Trandolapril-Verapamil in Patients with Stage 2 Hypertension Inadequately Controlled by Monotherapy

Abstract: A fixed-dose combination of trandolapril-verapamil seems to be an effective and safe option for the management of stage 2 hypertension in Mexican patients uncontrolled by monotherapy.

Cited by 5 publications

References 11 publications

A Prospective Noninterventional, Observational Study to Describe the Effectiveness and Safety of Trandolapril and Verapamil Single-Pill Combination in the Management of Patients with Hypertension and Type 2 Diabetes Mellitus: A Harvest TR Study

A Prospective Noninterventional, Observational Study to Describe the Effectiveness and Safety of Trandolapril and Verapamil Single-Pill Combination in the Management of Patients with Hypertension and Type 2 Diabetes Mellitus: A Harvest TR Study

Improving blood pressure control and clinical outcomes through initial use of combination therapy in stage 2 hypertension

Prompt, Aggressive BP Lowering in High‐Risk Patients

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